Table 4.
Results across 1,000 simulated studies for design version b). Average values and interquartile ranges provided
| S | T1E/ Power | Enrolled patients |
ESS | %Stop (1st interim) |
%Stop (2nd interim) |
w
(1st interim) |
w
(2nd interim) |
|---|---|---|---|---|---|---|---|
| 1 | 0.052* |
1511 (796–1578) |
17 (13–26) | 32 | 44 |
0.5 (0.5–0.5) |
0.5 (0.5–0.5) |
| 2 | 0.8 |
1846 (1578–2360) |
20 (13–26) | 13 | 41 |
0.5 (0.5–0.5) |
0.5 (0.5–0.5) |
| 3 | 0.052* |
1524 (796–2360) |
17 (13–26) | 34 | 38 |
0.5 (0.5–0.5) |
0.5 (0.5–0.5) |
| 4 | 0.83 |
1806 (1578–2360) |
20 (13–26) | 14 | 42 |
0.5 (0.5–0.5) |
0.5 (0.5–0.5) |
| 5 | 0.061* |
1490 (796–1578) |
18 (13–26) | 35 | 41 |
0.5 (0.5–0.5) |
0.5 (0.5–0.5) |
| 6 | 0.87 |
1821 (1578–2360) |
20 (13–26) | 12 | 44 |
0.5 (0.5–0.5) |
0.5 (0.5–0.5) |
| 7 | 0.055* |
1512 (796–2360) |
18 (13–26) | 34 | 41 |
0.5 (0.5–0.5) |
0.5 (0.5–0.5) |
| 8 | 0.87 |
1784 (1578–2360) |
19 (13–26) | 15 | 44 |
0.5 (0.5–0.5) |
0.5 (0.5–0.5) |
T1E: Type I Error rate (*); ESS: Effective Sample Size